sop for Breakdown Maintenance

1.0 PURPOSE
To define a procedure for handling of breakdown maintenance of equipment/ instrument.

2.0 SCOPE
2.1 This procedure applies to all the equipments instruments and utility equipments
3.0 REFERENCE
3.1 References
3.1.1 In-House

3.2 ANNEXURE
3.2.1 Annexure-I : Breakdown maintenance intimation slip.
3.2.2 Annexure-II : Log for issuance of Breakdown maintenance serial number.

4.0 ABBREVIATION

4.1 Breakdown Maintenance
Breakdown Maintenance is a set of measures taken to rectify faults that result in the failure of
equipment /instrument and restore it to normal functioning.

4.2 Abbreviations
4.2.1 CAPA: Corrective and Preventive Action
4.2.2 PMF: Planned Modification form
4.2.3 QA: Quality Assurance
4.2.4 SIP: Sterilization In Place

5.0 RESPONSIBILITY
5.1 Corporate Quality Assurance

5.1.1 To ensure the implementation of the procedure.
5.2 Concerned department:

5.2.1 To report the breakdown and label “under breakdown maintenance”.
5.2.2 To intimate the breakdown.
5.2.3 To verify the maintenance status.
5.3 Engineering department
5.3.1 To receive the intimation of breakdown.
5.3.2 To evaluate the reason for breakdown and rectify the problem
5.3.3 To investigate impact analysis of the breakdown, if required.
5.3.4 To maintain the equipment/ instrument history card of respective equipment/ instrument.
5.4 Quality Assurance
5.4.1 To ensure the proper documentation of the breakdown.
5.4.2 To allocate incident number, if required
5.4.3 To allocate the planned modification number, if required.
5.5 QA Head
5.5.1 To investigate impact analysis of the breakdown, if required.
5.5.2 To ensure implementation of defined procedure.
5.6 Plant Head
5.5.1 To investigate impact analysis of the breakdown, if required.
5.5.2 To ensure implementation of defined procedure.

6.0 Distribution:
I. Quality Assurance
II. Quality Control
III. Production
IV. Ware house
V. Engineering
VI. Environment, Health and safety

7.0 PROCEDURE:
7.1 Part-1 (For concerned department)
7.1.1 In case of equipment/instrument breakdown, the concerned department shall label it

with “Under Breakdown Maintenance” status label as per SOP
7.1.2 The concerned department shall fill the Following details in the breakdown maintenance

intimation slip and shall send to QA for evaluation as per Attachment-I (Break down Maintenance slip).
• Sr. No. of breakdown maintenance (Shall be allocated by QA).
• Name, code and location of equipment /instrument which has failed to work/ function.
• Nature of problem.
• Product and batch(s) number under impact.
• Remarks of department head.
• Intimated to QA by and date.
7.1.3 Reference of breakdown maintenance intimation slip serial number shall be entered in

sequential log of equipment / instrument.
7.2 Part-2 (For Quality Assurance)
7.2.1 QA shall allocate the Serial Number as per below system and record in log as per Attachment-II:
BM/YY/B-NNN
Where,
BM stands for Breakdown Maintenance:
YY stands for last two digits of current year, i.e. 20 for year 2020.
B stands for Block i.e.- B1 for Block 1
B2 for Block 2
U for Utility block
Q for Quality control/ Quality Assurance
A for Admin block
7.2.2 Breakdown maintenance serial number shall be maintained block wise at Quality Assurance.
7.2.3 QA shall ensure that proper documentation for the breakdown is done in sequential log of

the equipment /instrument which has failed to work and in relevant batch records.
7.2.4 QA shall allot deviation/incident number and mention in break down intimation slip (Attachment-I).
7.2.5 If required, QA shall give further remarks regarding impact evaluation or any other in addition

to remarks of concerned department head.
7.2.6 QA may hold the product batches if any under impact till further investigation.
7.2.7 After filling of all the details QA shall forward the breakdown maintenance intimation slip to concerned department.
7.3 Part-3 (For concerned department)
7.3.1 Concerned department shall acknowledge the comments of QA and initiate for the further

actions required which may be preparation of incident investigation report with impact analysis.
7.3.2 Concerned department shall forward the break down maintenance intimation slip to engineering department.
7.4 Part-4 (For Engineering)
7.4.1 Engineering department shall acknowledge the breakdown intimation details and impact evaluation

filled by concerned department and QA.
7.4.2 Based on the trend of breakdown/maintenance history and condition evaluation of the equipment
/instrument, renewal/replacement decision shall be triggered by Engineering department in

consultation with concerned department and QA.
7.4.3 Engineering department shall evaluate the need of filing planned modification in consultation with

QA and QA shall allot planned modification number (if required) and include in break down maintenance intimation slip.
7.4.4 Engineering department shall evaluate the reason for break down and rectify the problem.
7.4.5 After maintenance, if required machine trials shall be given to the concerned department while handing it over.
7.4.6 Engineering department shall evaluate the need for the passivation and sanitization of the

rectified equipment / instrument and perform the same.
7.4.7 Engineering department shall evaluate the need for recalibration or requalification in consultation

with QA and document the same in breakdown maintenance intimation slip. QA shall inform to concerned

department and qualification team for requalification or recalibration of that equipment / instrument.
7.4.8 Equipment /instrument history card shall be updated by the engineering department and necessary

parts checked while preventive maintenance and shall be updated in the preventive maintenance checklist.
7.4.9 In case of repetitive breakdowns, the preventive maintenance frequency /schedule may be revised.
Note: All the change (modifications/ part replacements) shall be recorded in equipment
/instrument history card.
7.4.10 Engineering department shall fill the following details in the breakdown maintenance intimation

slip and shall be forwarded to concerned department along with necessary attachments like,
planned modification form, copy of updated equipment / instrument history card, passivation record,

sanitization record, machine trial report, etc., if required.
• Reason for breakdown.
• Planned modification required / not required. If required PMF (Planned modification form) no.
• Corrective action taken.
• Passivation required / not required. If required, report no.
• Sanitization required / not required. If required, report no.
• Recalibration /calibration required / not required.
• Requalification / qualification required / not required.
• SIP qualification required / not required.
• History card updated by / date.
• Maintenance report (MR) checked and forwarded to concerned department by date and time.
• Maintenance report (MR) received by concerned department, date and time.

7.5 Part-5 (For Concerned department)
7.5.1 After maintenance, the concerned department shall verify the recalibration/calibration,

SIP qualification, requalification/qualification, Passivation, sanitization status in consultation

with QA and shall include reference document number for the same.
7.5.2 The concerned department shall include closing remarks if any and shall forward the breakdown

maintenance intimation slip to QA for evaluation along with necessary attachments like, copy

of sequential log, incident investigation report etc.

7.6 Part-6 (For Quality Assurance)
7.6.1 QA shall ensure that all actions suggested in the different parts of the breakdown maintenance

intimation slip are completed and wherever not completed, shall issue CAPA and monitor the same.
7.6.2 QA shall include but not limited to following status.
• Incident investigation status.
• Planned modification status.

• Recalibration /calibration, Requalification/qualification status.
• Impact evaluation status.
• Remarks on batch(s) disposition under impact of the breakdown.
• CAPA No.

8.0 REVISION HISTORY

Version No.	00	Effective Date
Details of revision: New SOP Prepared

Annexure-I

BREAKDOWN MAINTENANCE INTIMATION SLIP

Serial No.:
Part- 1 (For concerned department) To : Engineering	From (Department) : Date :
Equipment /instrument name :	Code :	Location :
Nature of problem :
Product under impact :
Batch(s) under impact :
Intimated to QA by : Date :	Remarks of department head : Sign/ Date:
Part- 2 (For quality assurance) Deviation/ Incident no.: Remarks for impact analysis / any other : Evaluated by : Date:
Part- 3 (For concerned department) Given for maintenance by : Date : Time : Received by (engineering) : Date: Time :
Part- 5 (For concerned department) Passivation report No.(If required) : Sanitization report No.(If required) : Recalibration / calibration record no. (if required): Requalification / qualification record no. (if required) : SIP qualification record no. (if required): Closing remark by department head: Sign : Date :
Part- 6 (For quality assurance) Incident investigation status : Planned modification status : Recalibration / calibration status : Requalification / qualification status: Impact evaluation status : Batch disposition status : CAPA no. *Note:* For more details provide attachments.

Annexure-II

LOG FOR ISSUANCE OF BREAKDOWN MAINTENANCE SERIAL NUMBER

BLOCK:-

Date	Breakdown Maintenance Serial No.	Department	Equipment/ Instrument Name	Equipment/ Instrument Code	Location	Nature of Problem/ Breakdown	Serial Number Allocated by QA (Sign/Date)	Reference Deviation/ incident No. (if any)	Reference CAPA No. (if any)	Closure Status/ Remarks